Merriam 2017.
Study characteristics | ||
Methods | RCT, 2 arms, 129 randomised (only including each women's first randomisation) Setting: USA, one centre Recruitment period: Jan 2014 ‐ Dec 2017 (provided by authors) |
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Participants |
Criteria related to previous IVF failure: no Inclusion criteria: all patients undergoing embryo transfer who are in the cycle prior to their embryo transfer Exclusion criteria: patients not undergoing embryo transfer, Known pregnancy, Active pelvic infection, Known endometrial hyperplasia or cancer, Inability to tolerate endometrial catheter placement, Severe cervical stenosis, patients who will receive operative hysteroscopy in the cycle prior to embryo transfer |
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Interventions | Study group 1: endometrial injury performed with pipelle on days 21‐27 in the cycle prior to the IVF cycle Study group 2: endometrial injury performed by a Shepard insemination catheter on days 21‐27 in the cycle prior to the IVF cycle | |
Outcomes | Reported in paper: live birth, pain Obtained by author correspondence: live birth, clinical pregnancy and pain data provided for the 129 women randomised. Miscarriage calculated as the difference between clinical pregnancy and live birth. |
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Notes | Trial registration: NCT04363879 (registered April 2020, registered retrospectively) Additional concerns and comments: none Funding: The protocol states quote: "This study does not have a budget. There will be no charge to the patient for the endometrial activation because the physicians have agreed to donate their time, and the procedures will be done in‐office" Author correspondence: yes, undertaken with Brad.Hurst@atriumhealth.org and goldrick@uthscsa.edu Publication: abstract only This study was presented as a conference abstract in 2017. The authors have since registered the trial and updated the 'Study Results' tab with information and a Statistical Analysis Plan. Information from all of these sources, including correspondence with the authors, has been used for the purposes of this review. During author correspondence it was discovered that the study had permitted re‐randomising of women. Therefore we have used data in this review from only each women's first randomisation ‐ and a total of 129 women were randomised. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The authors confirmed that a quote:"1:1 ratio of codes went into envelopes which were then shuffled and chosen at random to randomize patients" |
Allocation concealment (selection bias) | High risk | The authors confirmed that quote:"Envelopes were plain envelopes without writing on them", these do not meet the SNOSE criteria and are therefore considered high‐risk |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding was used. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The outcome of pain during the procedure was self‐reported by participants who were not blind to their treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | Women were excluded for not undergoing the endometrial scratch or an embryo transfer. Of 129 women, 13 were excluded (8 in the pipelle arm, 5 in the Shepard catheter arm) which is 10% of the 129 women recruited, therefore this is considered high‐risk |
Selective reporting (reporting bias) | High risk | The trial was registered retrospectively and important outcomes such as bleeding and miscarriage were not reported |
Other bias | High risk | Only an abstract is available. Although the authors provided additional data and clarification via email, it remains possible that important methodological detail that may result in bias has not been disclosed. Additionally, the trial was registered retrospectively. |